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Objective: To evaluate the efficacy and safety of adjunctive topiramate (sprinkle capsules or oral liquid) in reducing daily rates of partial-onset seizures (POS) in infants with refractory POS. Methods:In this double-blind, placebo-controlled, parallel-group, international study, infants (n ϭ 149) with clinical or EEG evidence of refractory POS were randomly allocated (1:1:1:1) to receive adjunctive topiramate 5, 15, or 25 mg/kg/d or placebo for 20 days. The primary variable was the median percentage reductions in daily POS rate from baseline to final assessment as recorded on a 48-hour video-EEG. Results:Of the 149 infants (mean age 12 months) included in the intent-to-treat analysis set, 130 completed the study. Median percentage reduction from baseline in daily POS rate was not significantly different (p ϭ 0.97) between topiramate 25 mg/kg (20.4%) and placebo (13.1%). Lower doses were not formally tested, but nominal p values for comparisons with placebo were not significant (15-mg/kg/d dose: p ϭ 0.97; 5-mg/kg/d dose: p ϭ 0.91). Treatment-emergent fever, diarrhea, vomiting, anorexia, weight decrease, somnolence, and viral infection occurred more frequently (Ն10% difference) with topiramate than with placebo. The incidence of newly diagnosed epilepsy is highest in the first year of life and includes many syndromes that are unique and are difficult to diagnose and classify. Conclusion:1,2 Also, seizure types and epilepsy syndromes evolve with age, making accurate diagnoses difficult or retrospectively incorrect in up to 25% of cases. 3,4 Contributing to the treatment challenges, many randomized controlled trials of newer antiepileptic drugs (AEDs) did not assess efficacy in children, and most available AEDs have not been rigorously investigated in infants, leaving physicians with incomplete data on which to base treatment decisions.5 A sizeable number of epilepsy syndromes are significantly different from those in adults. Therefore, clinical trial design in this population requires careful evaluation and must be different from adult trials.6 Drug dosing is also more difficult in children and often requires adjustment as the child matures. e-Pub ahead of print on January 20, 2010, at www.neurology.org. Investigators and institutions at which trials were performed are listed in appendix e-1 on the Neurology ® Web site at www.neurology.org.

Yoga is an age-old traditional Indian psycho-philosophical-cultural method of leading one's life, that alleviates stress, induces relaxation and provides multiple health benefits to the person following its system. It is a method of controlling the mind through the union of an individual's dormant energy with the universal energy. Commonly practiced yoga methods are 'Pranayama' (controlled deep breathing), 'Asanas' (physical postures) and 'Dhyana' (meditation) admixed in varying proportions with differing philosophic ideas. A review of yoga in relation to epilepsy encompasses not only seizure control but also many factors dealing with overall quality-of-life issues (QOL). This paper reviews articles related to yoga and epilepsy, seizures, EEG, autonomic changes, neuro-psychology, limbic system, arousal, sleep, brain plasticity, motor performance, brain imaging studies, and rehabilitation. There is a dearth of randomized, blinded, controlled studies related to yoga and seizure control. A multi-centre, cross-cultural, preferably blinded (difficult for yoga), well-randomized controlled trial, especially using a single yogic technique in a homogeneous population such as Juvenile myoclonic epilepsy is justified to find out how yoga affects seizure control and QOL of the person with epilepsy.

Objective:To evaluate the comparative safety and adjunctive efficacy of pregabalin and gabapentin in reducing seizure frequency in patients with partial-onset seizures based on prestudy modeling showing superior efficacy for pregabalin.Methods:The design of this comparative efficacy and safety study of pregabalin and gabapentin as adjunctive treatment in adults with refractory partial-onset seizures was randomized, flexible dose, double blind, and parallel group. The study included a 6-week baseline and a 21-week treatment phase. The primary endpoint was the percentage change from baseline in 28-day seizure rate to the treatment phase.Results:A total of 484 patients were randomized to pregabalin (n = 242) or gabapentin (n = 242). Of these, 359 patients (187 pregabalin, 172 gabapentin) completed the treatment phase. The observed median and mean in percentage change from baseline was −58.65 and −47.7 (SD 48.3) for pregabalin and −57.43 and −45.28 (SD 60.6) for gabapentin. For the primary endpoint, there was no significant difference between treatments. The Hodges-Lehman estimated median difference was 0.0 (95% confidence interval −6.0 to 7.0). Safety profiles were comparable and consistent with prior trials.Conclusions:The absence of the anticipated efficacy difference based on modeling of prior, nearly identical trials and the larger-than-expected response rates of the 2 antiepileptic drugs were unexpected. These findings raise questions that are potentially important to consider in future comparative efficacy trials.ClinicalTrials.gov identifier:NCT00537940.Classification of evidence:This study provides Class II evidence that for patients with partial seizures enrolled in this study, pregabalin is not superior to gabapentin in reducing seizure frequency. Because of the atypical response rates, the results of this study are poorly generalizable to other epilepsy populations.

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